Ozone is an unstable gas with a half-life of less than one hour at room temperature. The methods used to convert oxygen to ozone involve high voltage corona discharge or ultraviolet light. Ozone generators have been available for decades for industrial uses. Indeed, ozone is a powerful oxidizer and has been used for deodorizing air and purifying water. It is a known bactericide and viricide and recently has been used to sterilize medical instruments. Although, the cycle times are so long as to be impractical for many uses.
Ozone generators have been used for therapeutic applications for several years. Such applications include but are not limited to autohemotherapy, rectal insufflations, intradiscal injection, injection into knee and shoulder joints and full body exposure. Ozone has been used to treat diffuse bulging or contained herniation of the spinal disc.
Spinal discs are composed of a fibrous outer ring made of Type I collagen and a softer more flexible nucleus made of Type II collagen, proteoglycans and water. Patients with disc bulging or herniation suffer from pain caused by disc compression of the neurological elements, including the spinal cord, cauda equina and nerve roots. Intradiscal ozone treatment involves direct injection of a gaseous mixture of oxygen and ozone into the nucleus of the disc. Ozone releases water from the proteoglycans, reducing disc size and relieving compression of neurological elements. Some investigators believe that ozone stimulates anti-inflammatory mediators and initiates a healing response.
The mechanism of action and reported success rates of ozone treatment for spinal disc herniation are similar to that of the enzyme chymopapain. Chymopapain was first FDA-approved in 1983 and was widely used with a success rate of 65-85%. A small number of serious complications, including death and paralysis, caused the product to lose favor in the market and the product was eventually discontinued in the United States.
Ozone and chymopapain are two means of performing a chemical discectomy through a needle puncture. This minimally invasive approach may be preferred to surgical discectomy, which requires general anesthesia and direct access to the spinal disc.
Therapeutic ozone must be delivered practically immediately after being produced from oxygen. End-users of ozone such as doctors and health care professionals often procure medical grade oxygen from such sources as bulk tanks or a hopsital's wall supply of oxygen. Both of these sources are usually collect oxygen through cryogenic techniques. Although not previously used for ozone production, oxygen may also be concentrated from the ambient air using adsorption principles and zeolite materials. Existing medical ozone generators pass medical grade oxygen through an electric field or ultraviolet light. This process converts an amount of oxygen into ozone. A syringe is interfaced with the machine whereby ozone is withdrawn for subsequent injection therapy.
The preferred concentration of ozone for intradiscal injection is approximately 6%. The concentration of ozone is important for medical uses. If the concentration is too low the treatment will not be effective; if the concentration is too high detrimental effects may follow. As such, medical ozone generators must include a means for measuring the concentration of ozone. The elements necessary to create and measure ozone are sensitive and require maintenance to ensure precise and accurate operation.
Present ozone generators have basic means for controlling the concentration and delivery of ozone gas. Oxygen is generally passed through a machine containing permanent electrodes; the gas chambers of present generators are often permanent as well. Some generators include components that neutralize excess ozone. Other generators continuously vent ozone. Present ozone generators often include components for gas containment or pass oxygen through reaction chambers that are permanent and reusable, lending to sterility issues. Medical professionals often inject the gas through a bacterial filter to address such sterility issues.
The following patent publications illustrate and describe various background apparatuses, methods and/or systems related to generating ozone. US Patent Publication No. 2005/0074501 (Murphy et al.) teaches an apparatus, in an embodiment, including an ozone generator connected to a scavenger and an ozone administrator via network of tubing and valves. US Patent Publication No 2007/0025890 (Joshi et al.) teaches an apparatus that in various embodiments includes a syringe having a barrel and a plunger and having an ozone generator associated therewith. US Patent Publication No. 2003/0165411 (Engelhard) teaches an ozone generator that is a module having a threaded shaft serving as an electrode and which mechanically secures the various elements with one another. U.S. Pat. No. 6,270,733 (Rodden) teaches a tubular ozone generator comprising concentric inner tubular electrode/dielectric with inner electrode and outer tubular electrode with corona discharge zone between the inner tubular electrode/dielectric and outer tubular electrode. U.S. Pat. No. 6,110,431 (Dunder) teaches an ozone dispensing system comprising an ozone gas generating means, electrical means to control the concentration of ozone produced by said ozone gas generating means, means to control the concentration of ozone in preset dispensed volume, an oxygen supply and venting means disposed between said ozone gas generating means and said dispensing of said ozone, said venting means for continuous venting of said ozone. U.S. Pat. No. 5,052,382 (Wainwright) teaches an apparatus for the controlled generation and administration of ozone, which apparatus comprises a generator for generating ozone, a monitor for monitoring the ozone, a dosage device for providing a correct amount of ozone for administration, and a computer control device for controlling the operation of at least one of the generator, the monitor and the dosage device.
Similarly, the following patent publications illustrate and describe various background apparatuses, methods and/or systems for concentrating oxygen. U.S. Pat. No. 7,121,276 (Jagger et al.) teaches an oxygen separator, for separating oxygen from ambient air utilizing a vacuum swing adsorption process, having a mass of less than 2.3 kg. U.S. Pat. No. 6,949,133 (McCombs et al.) teaches a compact and highly portable combination pressure swing adsorption apparatus and product gas conservation device for medical use, to produce efficiently a gas with a high concentration of oxygen and to deliver the oxygen concentrated gas to a user at selectable times and in selectable doses. U.S. Pat. No. 6,520,176 (Dubois et al.) teaches an oxygen concentrator portable by a patient, permitting producing a flow of gas containing 50% to 95% of oxygen from air, comprising air compression device, elements for gas separation by adsorption with pressure variations, and electrical energy storage unit. U.S. Pat. No. 5,766,310 (Cramer) teaches a single stage secondary oxygen concentrator for receiving a gas mixture from a first stage oxygen concentrator and a method of use therefore.